Early Connections, Early Detection and Intervention in Infants at Risk for Autism

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by University of Washington.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Autism Speaks
Washington State Department of Social and Health Services
Autism Science Foundation
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00947700
First received: July 24, 2009
Last updated: September 2, 2010
Last verified: September 2010
  Purpose

Early connections has two broad goals:

  • to identify risk indices for autism spectrum disorder (ASD) in 6 to 24 month old infants who have an older sibling with ASD or infants who have an older neurotypical sibling.
  • to assess whether it is possible to alter risk processes through early intervention with high-risk infants, thereby reducing social-communication delays or the severity of autism symptoms.

Condition Intervention
Autism Spectrum Disorder
Behavioral: Assessment & Monitoring
Behavioral: Assessment, Monitoring & Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: UW ACE Project II, Early Detection and Intervention in Infants at Risk for Autism

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Autism Symptoms [ Time Frame: 12, 18 and 24 months ] [ Designated as safety issue: No ]
  • Mullen Receptive Language Scale [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Communication and Symbolic Behavior Scale [ Time Frame: 12, 18 and 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Parent Child Interaction [ Time Frame: 12, 18 and 24 m onths ] [ Designated as safety issue: No ]
  • Parent quality of life [ Time Frame: 12, 18 and 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: January 2008
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Assessment & Monitoring Behavioral: Assessment & Monitoring
Assessment & monitoring at 6, 12, 18 and 24 months.
Experimental: Assessment, Monitoring & Intervention Behavioral: Assessment, Monitoring & Intervention
Assessment and monitoring at 6, 12, 18 and 24 months; Parent delivered intervention provided between 6 and 12 months; and 12 and 18 months based on symptom severity

Detailed Description:

Researchers at the University of Washington want to learn more about the benefits of early monitoring and intervention for younger siblings of children with autism spectrum disorders (ASD). The information gained in this study may improve methods of early detection and intervention for infants who may be at risk for developing autism and lead to better outcome for these young children and their families.

Participants include families with a child who has been diagnosed with an autism spectrum disorder or typical development and a younger sibling 12 months old or younger. The study protocol includes: (1) comprehensive infant evaluations at the University of Washington Autism Center at 6-months, 12-months, 18-months and 24-months of age. (2) Developmental screening for the older sibling. (3) Questionnaires and phone interviews for parents. (4) Random assignment to an assessment and monitoring intervention group or a University of Washington intervention group. All families will receive advice regarding appropriate intervention services. Families who are assigned to the UW intervention will take part in a parent delivered intervention.

  Eligibility

Ages Eligible for Study:   5 Months to 12 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Older sibling with ASD (biologically related to participant)
  • Participant 12 months of age or younger
  • Within 1 hour of University of Washington
  • Interested in participating in Intervention

Exclusion Criteria:

  • Out of study area
  • Serious parent substance abuse or psychiatric history
  • Diagnosis of known genetic syndromes or neurological conditions (infant participant or older sibling)
  • Serious motor impairment (infant participant)
  • Significant prematurity (infant participant)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00947700

Contacts
Contact: Vanessa Rivera 1-800-994-9701 ddrinfo@u.washington.edu
Contact: Sara Webb, PhD 1-206-221-6461 sjwebb@u.washington.edu

Locations
United States, Washington
Center on Human Development and Disabilities, University of Washington Recruiting
Seattle, Washington, United States, 98195
Principal Investigator: Sara J Webb, PhD         
Principal Investigator: Annette Estes, PhD         
Sponsors and Collaborators
University of Washington
Autism Speaks
Washington State Department of Social and Health Services
Autism Science Foundation
Investigators
Principal Investigator: Bryan King, MD University of Washington
Principal Investigator: Sara J Webb, PhD University of Washington
Principal Investigator: Annette Estes, PhD University of Washington
  More Information

No publications provided

Responsible Party: Dr. Bryan H King MD; Professor and Vice Chair, Psychiatry and Behavioral Sciences, University of Washington
ClinicalTrials.gov Identifier: NCT00947700     History of Changes
Other Study ID Numbers: 32400-G, NIH P50 HD055782
Study First Received: July 24, 2009
Last Updated: September 2, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
Infants
Risk markers
ERP
Parent child interaction
Promoting First Relations
Social Communication

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on September 22, 2014